Effect of Face Masks on Pulmonary Function in Patients With COPD

Medical University of Vienna

Status: Enrolling

Conditions: Walking, Difficulty; COPD

Treatments: Procedure: Wearing a FFP2- Facemask; Diagnostic Test: 6 Minute Walking Test; Procedure: Wearing a Surgical Facemask; Diagnostic Test: Blood gas analysis; Procedure: Wearing no Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT05742880

1163/2022

Details and patient eligibility

About

Given the heightened vulnerability of COPD patients to severe illness upon SARS-CoV-2 infection, precautions like mask-wearing are deemed crucial. Yet, mask-wearing can exacerbate breathlessness and discomfort in this demographic. This study aims to assess the effects of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) among COPD patients.

Full description

In this detailed study, we aim to explore the impact of wearing face masks on COPD patients during 6-Minute-Walking-Tests (6MWT). COPD, commonly observed among smokers and former smokers, poses heightened mortality risks upon SARS-CoV-2 infection. Consequently, face masks are often recommended for preventive measures. However, breathlessness remains a predominant symptom in this patient cohort. Moreover, there is a dearth of data concerning blood oxygenation levels while wearing various types of face masks.

The study will involve COPD patients who will undergo three 6MWTs: one without a mask, one with a simple face mask, and one with a FFP2 mask. Prior to each 6MWT, comprehensive pulmonary function tests including spirometry, body plethysmography, and CO-diffusion capacity measurement will be conducted. Additionally, capillary blood gas analysis will be performed both before the 6MWT and after each test session.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD Diagnosis
• Vaccinated against SARS-CoV 2

Exclusion criteria

• Known cardial insufficency
• Long term oxgenation therapy
• immobility
• BMI >35
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Without Facemask

Sham Comparator group

Description:

Wearing no mask.

Treatment:

Procedure: Wearing no Mask

Diagnostic Test: Blood gas analysis

Diagnostic Test: 6 Minute Walking Test

Wearing a Facemask

Active Comparator group

Description:

Wearing a surgical facemask

Treatment:

Procedure: Wearing a Surgical Facemask

Diagnostic Test: Blood gas analysis

Diagnostic Test: 6 Minute Walking Test

Wearing a FFP2-Mask

Active Comparator group

Description:

Wearing a FFP2- Mask

Treatment:

Procedure: Wearing a FFP2- Facemask

Diagnostic Test: Blood gas analysis

Diagnostic Test: 6 Minute Walking Test